The PNH Registry
The PNH Registry: For All PNH Patients
The PNH Registry is a global, observational, noninterventional study collecting safety,
effectiveness, and quality-of-life data on patients with PNH. It was created in
response to requests from regulatory authorities at the Food and Drug Administration
(FDA) and the European Medicines Agency (EMEA) to collect long-term safety and effectiveness
data on patients treated with Soliris®. In its commitment to patients,
Alexion extended the charge of the registry to collect safety and additional information
on patients, whether treated with Soliris or not, in order to enhance the understanding
of the disease.
PNH Registry objectives: optimize patient management and outcomes
- To enhance the understanding of PNH demographics and natural history
- To capture the long-term outcomes of patients in order to better guide and assess
therapeutic interventions and the safety of Soliris
- To serve as a global resource for PNH information
The PNH Registry is designed to protect the confidentiality of patient data in accordance
with all applicable privacy regulations. All patients diagnosed with PNH can participate.
Benefits of participation: helping physicians and patients
The PNH Registry brings together physicians and patients from around the world. You
will be joining a global community of physicians contributing to the largest, most
comprehensive database on PNH.
Additional benefits of the PNH Registry include:
- Enhancing the understanding of PNH diagnosis and treatment
- Helping define treatment objectives, practice patterns, and best practices
- Promoting evidence-based medicine
- Promoting scientific collaboration in the PNH community
- Providing an opportunity to participate in periodic registry meetings to share data
and treatment experience
Because PNH is a rare disorder, the experience of every patient counts toward advancing
and understanding the disease while helping to raise awareness of PNH in the medical
community at large—please consider participating.
Who can contribute to the PNH Registry?
- All physicians treating PNH patients—regardless of therapy
- All patients who have been diagnosed with PNH are eligible to be enrolled
- All patients receiving Soliris are eligible to be enrolled
Data are entered at enrollment and approximately every 6 months thereafter. Physicians
are not required to examine patients at that time. Data entry minimally includes:
demographics, medical history, PNH diagnosis, flow cytometry, symptomology, safety
events, clinical outcomes, and pregnancy. Physicians will receive compensation for
participation.
The PNH Registry is sponsored by Alexion Pharmaceuticals and managed by ICON Clinical
Research.
Please contact the PNH Registry hotline:
Email:
PNHregistry@iconplc.com
Telephone: 1.800.913.4893
International: +1 215.616.3558